Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

Breast Cancer Clinical Trial

Official title:

Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04354064
• Other study ID #: 201903142
• Status: Recruiting
• Start date: May 29, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: Russell Pachynski, M.D.
• Phone: 314-286-2341
• Email: rkpachynski[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. This project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor DNA (ctDNA) molecular residual disease (MRD) detection timepoint. Ultimately, the integration of ctDNA into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible healthy donors will be at least 18 years of age.

Exclusion Criteria:

• Healthy donors younger than 18 years of age

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Esophageal Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Genitourinary Cancer
• Head and Neck Cancer
• Healthy Volunteer
• Lung Cancer
• Melanoma
• Prostate Cancer
• Sarcoma
• Skin Cancer
• Solid Tumor Cancer
• Urogenital Neoplasms

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (8)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Center for Advancing Translational Sciences (NCATS), National Institute of General Medical Sciences (NIGMS), Radiological Society of North America, Roche Sequencing Solutions, Skandalaris, The Foundation for Barnes-Jewish Hospital, The V Foundation for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from progression	-Defined as RECIST 1.1 based radiographic or clinical progression, with non-progressors censored at last radiographic follow-up	Through completion of study (estimated to be 6.5 years)
Secondary	Event-free survival	-Defined as post-treatment ctDNA detection or RECIST 1.1 based radiographic progression	Through completion of study (estimated to be 6.5 years)
Secondary	Disease-specific survival	-Defined as death from cancer	Through completion of study (estimated to be 6.5 years)
Secondary	Overall survival	-Defined as death from any cause	Through completion of study (estimated to be 6.5 years)
Secondary	Pathologic complete response rate		Through completion of study (estimated to be 6.5 years)
Secondary	Locoregional failure	-Defined as clinical or radiographic progression within the localized tumor/treatment area or regional lymph nodes	Through completion of study (estimated to be 6.5 years)
Secondary	Distant-metastasis-free survival	-Defined as clinical or radiographic progression outside the localized tumor/treatment area and regional lymph nodes	Through completion of study (estimated to be 6.5 years)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine